DCGI gives nod to Zydus Cadila for phase 3 clinical trials with biological therapy for COVID-19 vaccine

Zydus Cadila has received the go ahead from the Drugs Controller General of India (DCGI) for phase 3 clinical trials with its biological therapy PegiHep in COVID-19 positive patients.

The pharma company, in a regulatory filing, said it received approval from DCGI to start phase 3 clinical trials with its biological therapy Pegylated Interferon alpha-2b (PegiHep). The trials will be conducted on 250 patients across 20 to 25 centres in India.

Sharvil Patel, Managing Director of Cadila Healthcare Ltd, said they have been encouraged by the results of phase 2 study of Pegylated Interferon alpha 2-b which has shown the potential to reduce virus titres when given earlier in the disease. “Our efforts are to look at possible treatment options to fight COVID-19 which are safe, can be administered easily and also reduce the disease burden,” he said.

The pharma company said that its conducting a similar phase 2 trial in Mexico and also working with the US Food and Drug Administration (USFDA) to open an Investigational New Drug application for PegiHep, in order to initiate appropriate clinical trials in America.

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Zydus Cadila, in November, had said the company has taken a novel approach to its potential COVID-19 vaccine, using the DNA route. The DNA vaccine consists of genetic material of SARS-CoV-2 proteins. The genetic material instructs human cells to make SARS-CoV2 antigen, eliciting an immune response. “We don’t have any infectious agent as part of delivery technology, DNA vaccines have a very clear pathway both by the WHO and USFDA in terms of requirements for safety and efficacy,” Patel had explained. He highlighted that the vaccine can be stored at two to eight degrees temperature, making it a good fit for the existing cold chain infrastructure.

Moreover, the vaccine is administered through the intradermal route, which is much easier compared to intramuscular injection, which requires training of healthcare workers.